FDA Inspection 1060712 — Carnegie Science Center Henry J. Buhl Planetarium
The FDA completed an inspection of Carnegie Science Center Henry J. Buhl Planetarium on Jul 10, 2018 in Pittsburgh, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 10, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Pittsburgh, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5048 | 21 CFR 1010.4(d) | Variances - Improper certification |
| 5171 | 21 CFR 1040.10(g)(3) | Class IV "Danger" label |
| 5213 | 21 CFR 1040.11(c) | Demonstration laser products |
| 5705 | 21 CFR 1002.31(a) | Five year requirement |
| 5811 | 21 CFR 1002.30(a)(1) | Quality control procedures |
| 5813 | 21 CFR 1002.30(a)(2) | Methods, devices, procedures for testing |